On April 6, 2022 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the results from the NOPHO sponsored Phase 2 trial of eryaspase in ALL patients are now published in the British Journal of Haematology (Press release, ERYtech Pharma, APR 6, 2022, View Source [SID1234611600]).
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The Phase 2 NOR-GRASPALL-2016 trial evaluated the safety and pharmacological profile of eryaspase in ALL patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. The trial was conducted by the Nordic Society of Pediatric Haematology and Oncology (NOPHO) at 21 clinical sites in the Nordic and Baltic countries of Europe and enrolled 55 patients. Primary objectives of the trial were asparaginase enzyme activity and safety. Both endpoints were met.
Eryaspase demonstrated sustained asparaginase enzyme activity above the threshold of >100 U/L at trough levels 14 days after first infusion in 92.5% of patients. Eryaspase was generally well tolerated when added to chemotherapy and almost all patients were able to receive the intended courses of asparaginase (median of 5 doses per patient). Of the 55 patients, only 2 patients had severe allergic reaction and withdrew eryaspase treatment.
The Principal Investigator, Dr. Birgitte Klug Albertsen, Associate Professor at Aarhus University Hospital, Denmark, commented, "I am grateful that the editors of the British Journal of Haematology selected our study for publication. The study demonstrated that eryaspase, given as a convenient schedule every two weeks, provides a sustained asparaginase enzyme activity level above the recommended threshold for other Asparaginase treatments, few hypersensitivity reactions and is generally well tolerated in combination with chemotherapy. We conclude that eryaspase seems to be a promising treatment alternative for ALL patients with hypersensitivity to PEG-asparaginase."
"We are proud to be working with the NOPHO group in conducting this study in ALL, and hopeful that study results provide the possibility of an alternative treatment for ALL patients with hypersensitivity to PEG-asparaginase." said Dr. Iman El-Hariry, ERYTECH’s Chief Medical Officer. "We have an ongoing dialogue with the U.S. FDA regarding a potential regulatory approval in this indication based on the NOPHO-sponsored trial."
The paper: "Asparaginase Encapsulated in Erythrocytes as Second-line Treatment in Hypersensitive Patients with Acute Lymphoblastic Leukaemia" by Line Stensig Lynggaard, Goda Vaitkeviciene, Cecilia Langenskiöld, Anne Kristine Lehmann, Päivi M. Lähteenmäki, Kristi Lepik, Iman El Hariry, Kjeld Schmiegelow, and Birgitte Klug Albertsen, can be viewed online at View Source, appearing in British Journal of Haematology, 2022;00:1– 10, published by Wiley.
For additional information and copies of the paper, please contact Wiley at View Source
About Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and Europe. More than 13,000 cases are diagnosed in the US and Europe each year with the majority of patients diagnosed
before age 20. Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment- limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with
inferior event free survival highlighting the need for additional asparaginase based treatment options.